A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPuma Biotechnology, Inc.
About this trial
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
Eligibility criteria
Qualifiers
Aged ≥18 years at signing of informed consent
Pathologically confirmed SCLC
Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens
Disqualifiers
Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Trial design
Treatments tested in this trial
- Alisertib
Treatment groups
120 Participants
are divided into 1 treatment groupLocations
30Alabama
Southern Cancer Center36526, Daphne United States
California
The Oncology Institute of Hope and Innovation90805, Long Beach United States
Colorado
Rocky Mountain Cancer Centers80124, Lone Tree United States
District of Columbia
Georgetown Lombardi Cancer Center20057, Washington D.C. United States
Sponsors and collaborators
Puma Biotechnology, Inc.
Lead sponsor
Source ClinicalTrials.gov